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Sign in to claim this brandArthrex, Inc.
United States·US-MF-000019271
Last updated September 17, 2026
What Arthrex, Inc. makes
Arthrex, Inc. manufactures orthopaedic fixation devices, including non-sliding bone screws, non-bioabsorbable fixation plates, and bioabsorbable tendon/ligament anchors. The company also produces reusable surgical tools such as drill guides, suturing units, and sterilization/disinfection containers. Polyolefin/fluoropolymer multifilament sutures and arthrodesis intramedullary nails are part of its portfolio.
The portfolio includes devices classified as Class I, Class II, and Unclassified (U) under FDA regulations, with submissions recorded via 510(k) and UDI pathways. These products are listed in the FDA’s regulatory databases and are intended for orthopaedic surgical applications.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Arthrex, Inc. manufacture?
Arthrex, Inc. specializes in orthopaedic devices primarily used in surgical fixation and repair. Their portfolio includes non-sliding bone screws, non-bioabsorbable fixation plates, reusable surgical tools like drill guides and suturing units, bioabsorbable tendon/ligament anchors, and polyolefin/fluoropolymer multifilament sutures. They also produce arthrodesis intramedullary nails and reusable sterilization/disinfection containers, all designed for orthopaedic procedures.
Where is Arthrex, Inc. based, and what does that mean for its regulatory oversight?
Arthrex, Inc. is based in the United States, which means its devices fall under FDA regulatory jurisdiction. The FDA classifies their products as Class I, Class II, or Unclassified (U), depending on risk levels. Since the company operates in the US, submissions for device authorization—such as 510(k) premarket notifications or Unique Device Identifier (UDI) listings—are recorded in the FDA’s official databases.
Which regulatory registries or databases list Arthrex’s devices?
Arthrex’s devices are documented in the FDA’s regulatory databases through two primary pathways: 510(k) submissions for premarket clearance and UDI (Unique Device Identifier) listings. These registries ensure traceability and compliance tracking for orthopaedic fixation devices, reusable surgical tools, and related products authorized under FDA guidelines.
How are Arthrex’s devices classified under FDA regulations?
Arthrex’s devices are categorized into three FDA classes: Class I (low-risk, generally exempt from strict premarket controls), Class II (moderate-risk, requiring special controls like 510(k) submissions), and Unclassified (U) for products not yet assigned a risk level. Classification determines the regulatory pathway—e.g., 510(k) notifications for Class II—ensuring appropriate oversight based on device risk.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 1370 Creekside Blvd, Naples, United States
- Website
- www.arthrex.com/
- —
- —
- [email protected]
- Phone
- +1 800 934-4404
- PRRC Contact
- Amanda Webb
- EUDAMED SRN
- US-MF-000019271
- FDA FEI Number
- 1220246
- DUNS Number
- 131747628
Catalogue (17147)
Page 25 of 343| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Sonoma Orthopedic Products, Inc | 2.7mm x 34mm Self-Tapping,Sterile Bone Screw | FDA UDI | Class II | Unknown |
| Arthrex® | AR-18720VCL-16 | FDA UDI | Class II | Active |
| Arthrex® | AR-S3375-200-YEL | FDA UDI | Class I | Active |
| Arthrex® | AR-9096A-11-34R | FDA UDI | Class II | Active |
| Arthrex® | AR-1938BC | FDA UDI | Class II | Active |
| Arthrex® | AR-8656-80 | FDA UDI | Class I | Active |
| Arthrex® | AR-8930D-13-RU | FDA UDI | Class I | Active |
| Arthrex® | AR-9503-3633-6 | FDA UDI | Class II | Active |
| Arthrex® | AR-9564-2439-LAT | FDA UDI | Class II | Active |
| Arthrex® | AR-9096A-13-36L | FDA UDI | Class II | Active |
| Arthrex® | AR-8740BV-30S | FDA UDI | Class II | Active |
| Arthrex® | AR-S7400-035-330 | FDA UDI | Class I | Active |
| Arthrex® | AR-8933VCL-56 | FDA UDI | Class II | Active |
| Arthrex® | AR-S3420-110-13440 | FDA UDI | Class I | Active |
| Arthrex® | AR-3600-1 | FDA UDI | Class II | Active |
| Arthrex® | AR-8835-32S | FDA UDI | Class II | Active |
| Arthrex® | SP-643-51 | FDA UDI | Class I | Active |
| Arthrex® | AR-S3420-080-15540 | FDA UDI | Class I | Active |
| Arthrex® | AR-8835-44S | FDA UDI | Class II | Active |
| Arthrex® | AR-2872 | FDA UDI | Class I | Active |
| Arthrex® | AR-8916-12 | FDA UDI | Class I | Active |
| Arthrex® | AR-7000-30S | FDA UDI | Class II | Active |
| Arthrex® | AR-3375-2407 | FDA UDI | Class I | Active |
| Arthrex® | AR-9943PLTL-04T | FDA UDI | Class I | Active |
| Arthrex® | AR-18827P-48 | FDA UDI | Class II | Active |
| Arthrex® | AR-9241-02 | FDA UDI | Class I | Active |
| Arthrex® | AR-4058V-P15 | FDA UDI | Class I | Active |
| Arthrex® | AR-3636 | FDA UDI | Class II | Active |
| Arthrex® | AR-9510-FX6NT | FDA UDI | Class I | Active |
| Arthrex® | AR-8916SPN-ST | FDA UDI | Class II | Active |
| Arthrex® | AR-1662BC-9-1 | FDA UDI | Class II | Active |
| Arthrex® | AR-8835-40S | FDA UDI | Class II | Active |
| Arthrex® | AR-8935V-34 | FDA UDI | Class II | Active |
| Arthrex® | AR-300DAO-1 | FDA UDI | Class I | Active |
| Arthrex® | AR-3380-4052H | FDA UDI | Class I | Active |
| Arthrex® | AR-8725-20H | FDA UDI | Class II | Active |
| Arthrex® | AR-11450 | FDA UDI | Class I | Active |
| Arthrex® | AR-13402-50 | FDA UDI | Class II | Active |
| Arthrex® | AR-9673-25T | FDA UDI | Class I | Active |
| Arthrex® | AR-4553 | FDA UDI | Class II | Active |
| Arthrex® | AR-8771-0225S | FDA UDI | Class II | Active |
| Arthrex® | AR-9552-20RCA | FDA UDI | Class II | Unknown |
| Arthrex® | AR-9261-44 | FDA UDI | Class I | Active |
| Arthrex® | AR-1600-8 | FDA UDI | Class I | Active |
| Arthrex® | AR-8835VCL-110 | FDA UDI | Class II | Active |
| Arthrex® | AR-8835VCL-50 | FDA UDI | Class II | Active |
| Arthrex® | AR-8750-09-RU | FDA UDI | Class I | Active |
| Arthrex® | AR-8933-46S | FDA UDI | Class II | Active |
| Arthrex® | AR-12120F | FDA UDI | Class I | Active |
| Arthrex® | AR-9165ADG | FDA UDI | Class I | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Arthrex GmbH Munich Bavaria · DE FEI 3002579136